Vertex Pharmaceuticals

Compliance

• Responsible for the ongoing monitoring and management of compendial updates for clinical and commercial programs
• Ensure compliance with global pharmacopoeia standards and regulatory submissions
• Maintain alignment with the European Pharmacopoeia (EP), United States Pharmacopeia (USP), and assist in expanding the program to include additional international pharmacopeia such as the Mexican Pharmacopoeia (Mexico Ph), Chinese Pharmacopoeia (ChP), and Japanese Pharmacopoeia (JP)
• Continuously monitor updates and revisions to EP, USP, Mexico Ph, ChP, and JP and others as programs expand
• Analyze changes in compendial requirements, work with SMEs to assess impact on company products, processes, regulatory submissions and documentation
• Provide regular updates to internal stakeholders, including regulatory, quality, and manufacturing teams, on compendial changes and their implications
• Ensure timely implementation of compendial changes to maintain compliance with regulatory requirements
• Develop and oversee the execution of Corrective and Preventive Actions (CAPAs) to address any gaps or non-compliance issues identified during compendial reviews
• Track and ensure completion of all CAPAs before implementation deadlines
• Assist leading the expansion of the compendial monitoring program to include Mexico Ph, ChP, and JP and others
• Establish processes and procedures for monitoring and integrating updates from these additional pharmacopoeias
• Maintain accurate and up-to-date records of compendial changes, assessments, and actions taken
• Prepare and present detailed reports on compendial updates, compliance status, and CAPA progress to management and relevant teams
• Collaborate with cross-functional teams, to ensure alignment and effective implementation of compendial changes
• Act as the primary point of contact for compendial-related inquiries and guidance

Global GxP Regulatory Intelligence Compendia Manager – Contract

Manager

• Serve as a Strategic Document Partner for assigned functional areas and/or quality system(s), aligning document development and records management with business, quality, and regulatory expectations
• Serves as a Process Documentation architect for the Global QMS
• Partners with Quality System Owners, Process Architecture and Digital Quality Systems to ensure documentation accurately reflects end-to-end process design, is structured for usability and compliance, and is fully integrated with training, systems and change management.
• Act as a liaison between functional area leadership and the GxP Document and Training Strategy and Operations teams, ensuring alignment of documentation goals with operational and quality objectives
• Conduct document impact and needs analyses and supports the functional document hierarchy which integrates the development, maintenance, and distribution of critical documents that support the organization’s strategic goals and initiatives to reduce documentation complexity and redundancy.
• Partner with stakeholders to ensure the document and records management process along with documentation assumes a risk-based approach and reflects current industry and regulatory standards
• Collaborate with QSO, Process Owners (PO), Document and Training Operations, and functional area partners to support inspection-ready documentation and records.
• Leverage automation, digital tools, and emerging technologies, including AI and Machine Learning, to optimize documentation processes and content to improve usability and accessibility of documentation
• Identify opportunities to enhance document and records management processes, content, and delivery methods by leveraging feedback and data-driven insights
• Promote a culture of change by driving continuous improvement initiatives that improve documentation impact and efficiency
• Evaluate documentation quality system effectiveness using appropriate metrics to ensure objectives are met and compliance requirements are achieved
• Support the Documentation QSO and PO in implementing the strategic documentation and records management roadmap by overseeing the development and delivery of document initiatives
• Collaborate with Strategic Document Partners to ensure consistent and effective application of best-in-class practices across the organization
• Serve as an escalation point for operational challenges, providing solutions to support uninterrupted document operations
• Collaborate with leadership to troubleshoot and resolve document-related issues effectively
• Partner with Strategic Learning Partners to oversee GxP document control processes related to training, ensuring accuracy, accessibility, and compliance of training materials
• Partner with Continuous Improvement to streamline processes

Senior Manager, GxP Strategic Document Partner

• Act as the primary training and learning partner for assigned business areas, developing a strong understanding of core processes and workflows.
• Conduct learning and performance needs analyses to determine the most effective learning approach.
• Design learning solutions grounded in adult learning principles, focusing on relevance and application.
• Develop learning architectures and pathways aligned to business and regulatory requirements.
• Ensure learning solutions are practical, scalable, and aligned with inspection expectations.
• Partner with Quality, Document Control, and business SMEs to support inspection-ready training records.

Senior Manager, GxP Strategic Training Partner, CMC

• Accountable for leading publishing activities on a portfolio level
• Responsible for the maintenance and lifecycle management submissions
• Lead complex submission work across programs
• Ensure submission content is tracked, compiled, validated, and delivered in the required format
• Perform quality control (QC) reviews on vendor work
• Contribute to long-term resource planning, including publishing capacity needs

Associate Director, Regulatory Publishing

• Format complex regulatory documents in Microsoft Word to meet submission-ready standards.
• Apply structured formatting, hyperlinks, bookmarks, cross-references, and linking best practices.
• Convert Word source files into compliant, high-quality PDFs.
• Work within Veeva Vault Publishing to manage document workflows and dynamic linking functionality.
• Support report-level publishing (e.g., clinical reports, protocols, periodic reports).
• Ensure alignment with global regulatory publishing standards and eCTD requirements.
• Partner with document authors and SMEs to build quality into Word source documents early.
• Provide guidance on submission-ready formatting standards.
• Support refinement of evolving submission checklists and templates.
• Manage multiple concurrent document priorities independently.

Regulatory Publishing Manager – Contract

Accounting Manager

• Lead the team's revenue recognition evaluation (ASC 606) relating to new product launches, new contracts and reimbursement agreements
• Partner with a cross functional team that reviews and supports the contract drafting process
• Lead accounting review of new agreements and/or complex gross to net; ensure technical accounting conclusion is applied appropriately by local accounting teams
• Lead documentation of accounting policies (focus on revenue and gross to net) work with International and North America revenue accounting as needed
• Build partnerships with global accounting, finance and commercial organizations in support of financial reporting requirements both internal and external
• Partner with SEC Reporting team to prepare revenue related disclosures supporting SEC filings
• Play a key role in the Company's quarterly and annual reviews and audit including the preparation of revenue recognition memos, audit schedules and other auditor requests
• Partner with International Accounting Team in support of statutory audits and financial statements

Senior Revenue Accounting Manager – Contract

Procurement

• Lead the implementation and optimization of marketing buying channel platforms
• Strengthen marketing procurement processes and enhance supplier performance management
• Utilize Scope of Work (SOW) tools effectively and oversee rollout of the Scope of Work tool
• Develop and implement clear Ways of Working and structured Planning Process Calendar
• Design and optimize analytics dashboards to maximize procurement tools
• Establish and embed a comprehensive Supplier Performance and Relationship Management framework
• Provide guidance, mentorship, and subject matter expertise to team members and cross-functional partners

Senior Manager, Procurement – Contract

Attorney

• Oversee the end-to-end electronic billing process, including invoice submission, review, and approval, using the company’s eBilling platform (CounselLink)
• Ensure compliance with company billing guidelines and legal department policies
• Monitor and resolve billing discrepancies, rejections, and appeals in a timely manner
• Collaborate with law firms and vendors to address billing issues and ensure accurate submissions
• Create and manage new matters in the eBilling system upon request from attorneys or law firms
• Maintain consistent naming conventions and metadata standards to support accurate reporting and tracking
• Coordinate with Procurement and Legal Operations to onboard new law firms and vendors
• Set up and maintain vendor profiles, billing contacts, and tax information within the eBilling system
• Communicate billing guidelines, invoice formats, and system expectations to new vendors
• Collect and validate monthly or quarterly accrual estimates from law firms and vendors
• Review and process new timekeeper rate requests in the eBilling system
• Act as the central point of contact for all eBilling-related inquiries from law firms, vendors, and internal users
• Provide real-time troubleshooting and escalate system or configuration issues to the eBilling platform’s support team as needed
• Maintain consistent communication between Finance, IT, and Legal Operations to ensure alignment on billing processes and issue resolution.

eBilling Specialist – Contract

Engineer

• Responsible for the day-to-day administration of the Vertex data classification and protection systems
• Consult with members of the technical and business communities to identify and label Vertex data
• Analyze and resolve complex software and hardware problems
• Ensure correct processes are followed in change management for tracking and reproducibility
• Create training materials to expand the adoption of identifying and labeling data using Microsoft 365 Sensitivity Labels
• Independently create data usage reports and integrate new sources of Vertex data